ISO 9001-Clause 5.5

ISO 9001-Clause 5.5 Responsibility, authority and communication

ISO 9001-Clause 5.5.1 Responsibility and authority

ISO 9001 requirement:
Top management shall ensure that responsibilities and authorities are defined and communicated  within the organization.
Top management must establish the organization necessary to deploy the QMS. It must define the structure, hierarchy and lines of reporting. Additionally,  it must ensure that duties, responsibilities and authority of all personnel are defined and communicated. All personnel must be clear on their duties, responsibilities and authority in meeting customer and regulatory requirements. Organization charts, job descriptions, Standard operating procedures, work instructions, etc, are some of the many ways that top management may use to define and document this. These must be communicated and deployed, as applicable, throughout the organization. Orientation training, appointment postings, training on procedures and work instructions, etc, are some of the many ways in accomplishing this.The organization structure and lines of reporting; responsibility and authority of managerial functions and departments may be established by top management  and the responsibilities and authorities for the rest of the organization may be established by the HR function working with various process owners. Again, this would depend on the size, complexity and culture of the organization.The effective planning, operation and control of internal communication processes may be demonstrated through the performance indicators.

ISO 9001-Clause 5.5.2 Management representative

ISO 9001 requirement:
Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
b) reporting to top management on the performance of the quality management system and any need for improvement, and
c) ensuring the promotion of awareness of customer requirements throughout the organization.
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
A member of management, who has sufficient authority to effectively carry out QMS responsibilities should be appointed as the MR of the organization .  The MR’s role is to facilitate, motivate and promote the deployment of QMS requirements throughout the organization, through guidance, training, teamwork and assistance. In carrying out QMS responsibilities, the MR may need to communicate, delegate, empower, report, oversee and interact with individuals at all levels internal and external to the organization. Irrespective of other responsibilities” means that the MR may wear other hats and the MR hat does not have to be the primary one. Regardless, once appointed as the MR, the individual must effectively perform all QMS responsibilities specified in this sub-clause. Much of this can be done through having access to appropriate resources and through delegation. Top management may show evidence of the appointment of the MR through an appointment posting, attendance at QMS review meetings, provision of support, authorization and resources to QMS activities.Since quality is the responsibility of the entire organization, the role of the MR is to assist process owners in developing their processes according to the requirements of  ISO 9001 relevant to their process. For example the purchasing, production or warehousing processes must also know how to control nonconforming product (clause 8.3); take corrective action (clause 8.5.2) or control their records (clause 4.2.4); etc.
Reporting to top management on QMS performance may take place at management review meetings or other meetings. The information for the report will come from the results of the measurement and monitoring requirements specified in clause 8 (e.g. internal audits and customer satisfaction feedback, etc.). The MR must delegate and facilitate the compilation of this information from all the process owners. The report must include any recommendation to improve the QMS based on the MR’s review of all QMS measurement and monitoring data. It would be appropriate to discuss and obtain agreement with affected process owners. ISO 9001 focuses heavily on meeting customer and regulatory requirements and enhancing customer satisfaction. The MR must likewise promote this focus through all processes that are directly and even indirectly involved in achieving this. There are many ways of doing this including the use of training, cross-functional teams, customer focused project teams, project milestone reviews, designated customer representative, interfaces with the customer, customer specifications, customer product specific work instructions, etc.The MR’s activities must be included in quality planning, management review and communication processes.Overall QMS performance indicators may be used to determine how well the MR has performed the responsibilities.

ISO 9001-Clause 5.5.3 Internal communication

ISO 9001 requirement:
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
Communications is a complex and difficult activity. Problems may arise due to incomplete, ambiguous or inaccurate information being transmitted; transmission to the wrong person, too late or at the wrong time; use of inappropriate or unreliable media, etc. Communication problems are probably the most common cause of QMS nonconformities. Tracking some of the more serious communication issues could serve as useful performance indicators to determine and improve communication process effectiveness. Clause 4.1 control of processes requires you to determine the sequence and interaction of QMS processes. Each process requires inputs to flow from one process and outputs to flow to another process. There is a continuous (communication) flow regarding tangible (materials and product) and intangible (information) inputs and outputs taking place within your organization.
Top management must plan for internal and external communication methods and resources at the high level using the business planning process and deploy these methods though the information technology, logistic and HR processes.Each process owner must identify the methods of communication  such as computer, documents, telephone, meetings, directives, visual, etc,used and determine whether these methods are appropriate  and are they effective for the purpose intended? – (do they prevent non-conformities from arising due to the reasons mentioned above?). Process owners should provide feedback on communications effectiveness to the processes providing and controlling such resources. Communication by the MR on the effectiveness of the QMS must not only take place at the top management level but also at appropriate levels within the organization. If everyone is responsible for quality, then all process owners as well as their personnel are entitled to receive periodic feedback on their areas of responsibility. ISO 9001 clauses that specify communication requirements include- 4.1.d; 5.1.a; 5.3.d; 5.5.1; 5.5.2.b; etc.

Audit Checklist

For sub-Clause 5.5.1:

  •  Are the responsibilities & authority for various functions defined & communicated to facilitate effective quality mgmt?
  • Do Organization Charts/Job Descriptions exist? Are they current and accurate? Cover all personnel identified in the QMS?
  •  How do we publish, or make available, this information?

For sub-Clause 5.5.2:

  •  Is a management representative appointed by top management to ensure the processes of the QMS are established, implemented and maintained?
  • Is Management Representative  identified? How? Shown on Organization Chart?
  •  Are responsibilities of Management Representative identified? How do they maintain the QMS?
  •  How do MR report on QMS performance to the Top Management? How do they find  improvements?
  • How do MR promote awareness of customer requirements throughout the organisation?
  • How do MR liaise with external parties on matters relating to the QMS?

For sub-Clause 5.5.3:

  • Are the processes of the QMS and their effectiveness communicated between various levels and functions within the organisation?
  • How is information circulated or distributed to personnel regarding business operating performance? Is it systematic? Regular meetings?
  • Do report distribution lists exist? (Check people shown on distribution lists and confirm they receive the reports)
Mandatory Procedure :

Clause 5.5.1: Not applicable
Clause 5.5.2: Not applicable
Clause 5.5.3: Not applicable

Mandatory record:

Clause 5.5.1:Not applicable
Clause 5.5.2:Not applicable
Clause 5.5.3: Not applicable

Evidence/Implementation document ( Not mandatory but helps in fulfillment of requirement):

Clause 5.5.1:
Clarity on their duties, responsibilities and authority: Organization charts, job descriptions, procedures, work instructions, Orientation packages, appointment postings, sign-off on job descriptions, training on procedures and work instructions, etc,
Documentation of control methods could include technical manuals, training provided, signage, computer system etc.
Organization chart( can be part of Quality Manual)
Job Description ( can be a separate document or part of Quality Manual)

pdf Example of Organization chart
pdf Example of job description

Clause 5.5.2:
Enhancing customer satisfaction: the use of training, cross-functional teams, customer focused project teams, project milestone reviews, designated customer representative, electronic interfaces with the customer, customer specifications, customer product specific work instructions.
Job Description of Management Responsibility ( can be a separate document or part of Quality Manual)
Management Review Record
Clause 5.5.3:
Minutes of Meeting

pdf Example of Format of Minutes of Meeting

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Pretesh Biswas

Pretesh Biswas